MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number 10371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 07/16/2020

Event Type  Injury  

Event Description

It was reported that perforation and pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.A trace effusion was noted at the beginning of the procedure.The procedure was performed with intracardiac echo and the device was successfully deployed and released with no issues.The was was not deeply seated; however, there was a large pectinate at the distal tip of the laa that held the device feet closed until the shoulders of the device detached out of the sheath.At the end of the procedure the effusion was noted to be much larger.A pericardiocentesis was performed and 1.25 liters of fluid was removed in the operating room.The patient's blood pressure dropped from 125 to 74 systolic but the patient remained stable.Two units of packed red blood cells and two units of fresh frozen plasma were given.Per the surgeon, a 1mm perforation was noted at the distal end of the laa.The patient had uneventful night and was extubated the following morning but remained stable and was discharged.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10373515
• MDR Text Key: 201876831
• Report Number: 2134265-2020-09994
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024787293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR